IS 10258:2002 ISO 7886-1:1993 (Reaffirmed - 2012) Indian Standard STERILE HYPODERMIC SYRINGES FOR SINGLE USE (Second Revision ) ICS 11.040.20 0 BE 2002 BUREAU MANAK OF BHAVAN, INDIAN STANDARDS ZAFAR MARG 9 BAHADUR SHAH NEW DELHI 110002 June 2002 Price Group 9 Medical Instruments and Disposable Sectional Committee, MHD 12 NATIONAL FOREWORD This Indian Standard (Second Revision) which is identical with ISO 7886-1:1993 `Sterile hypodermic syringes for single use ­ Part 1: Syringes for manual use' issued by the International Organization for Standardization (ISO) was adopted by the Bureau of Indian Standards on the recommendations of Medical Instruments and Disposable Sectional Committee (MHD 12) and approval of Medical Equipment and Hospital Planning Division Council. This standard was first published in 1982. It was revised in 1995 to incorporate method of test for carrying out sterility test and to harmonize with ISO 7886-1 : 1993 to the extent possible. Its second revision has been taken up to align its requirements with ISO 7886-1 : 1993 and adopt it as a dual number standard. In this standard tests, for toxicity have been replaced by an informative cross-reference to IS 12572 (Part 1) : 1994/1S01 0993-1 : 1992 `Biological evaluation of medical devices: Part 1 Guidance on selection of tests (first revision)'. This standard covers sterile hypodermic syringes intended for single use primarily in humans. It does not specify requirements for freedom from biological hazards. Guidance on biological evaluation and tests relevant to hypodermic syringes are given in IS 12572 (Part 1) : 1994/1S01 0993-1 :1992 and it is suggested that manufacturers take this guidance into account when evaluating products. Such an evaluation should include the effects of the process whereby the needles are sterilized. Materials to be used for the construction of needles are not specified as their selection will depend to some extent upon the design, process of manufacture and method of sterilization employed by individual manufacturers. Guidance on some aspects of the selection of materials is given in Annex E. The materials should be compatible with injection fluids. If this is not the case, the attention of the user should be drawn to the exception by Iabelling the primary container. It is not practicable to specify a universally acceptable test method for incompatibility. However, recommended methods are given in Annex F. These test methods can be regarded only as a means of indicating compatibility. The only conclusive test is that of an individual injection fluid with a specific syringe. Manufacturers of pharmaceuticals use solvents in injectable preparations. Such solvents should be tested by the manufacturer of the injectable preparation for any possible incompatibility with the materials frequently used in syringe construction. The types of material that have received wide acceptance are included in Annex E. If an incompatibility exists, the injection should be suitably labelled. The impossibility of testing any one injection fluid with all available syringes is recognized and it is strongly recommended that regulatory authorities and relevant trade associations should recognize the problem and take appropriate measures to assist manufacturers. Hypodermic syringes specified in this standard are intended for use with hypodermic needles specified in IS 10654: 2002/l SO 7864: 1993 `Sterile hypodermic needles for single use (third revision)'. Where Indian Pharmacopoeia or other government may take precedence over this Indian Standard. Annexes A, B, C and D forms an integral information only. regulations are legally binding, these requirements part of this standard. Annexes E, F, G, H and J are for The text of standard has been approved as suitable for publication as Ind[an Standard without deviations. Certain conventions are, however, not identical to those used in Indian Standards. Attention is particularly drawn to the following: a) Wherever the words `International read as `Indian Standard'; and Standard' appear referring to this standard, they should be b) Comma (,) has been used as a decimal marker while in Indian Standards, is to use a point (.) as the decimal marker. the current practice (Continued on third cover) IS 10258:2002 ISO 7886-1 :1993 Indian Standard STERILE HYPODERMIC SYRINGES FOR SINGLE USE (Second Revision ) 1 Scope This part of ISO 7886 specifies requirements for sterile single-use hypodermic syringes made of plastics materials and intended for the aspiration-of fluids or for the injection of fluids immediately after filling. It excludes syringes for use with insulin (see ISO 8537), single-use syringes made of glass, syringes with needles permanently attached, syringes for use with power-driven syringe pumps, syringes pre-filled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. A second part of ISO 7886 is being prapared to cover syringes for use with powerdriven syringe pumps. NOTE 1 ISO 8601:1988, Data elements and interchange formats -- Information interchange -- Representation of dates and times. 3 Definitions For the purposes of this part of ISO 7886, the following definitions apply. 3.1 nominal capacity:Capacity of the syringe as designated NOTE 2 3.2 by the manufacturer. Examples are 1 ml, 5 ml, 50 ml 2 The Normative references graduated capacity Volume of water at (20 + 5) `C [or, for tropical countries (27 * 5) "C] expelled from the syringe when the fiducial line on the piston traverses a given scale interval or intetvals. 3.3 total graduated capacity Capacity of the syringe at the graduation line furthest from the zero graduation line, NOTE 3 The total graduated capacity may be equal to, or greater than, the nominal capacity. 3.4 maximum usable capacity: Capacity of the syringe when the piston is drawn back to its furthest functional position. 3.5 fiducialhe: Line circumscribing the end of the piston for determining the capacity corresponding to any scale reading of the syringe. following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO 7886. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of ISO 7886 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 594-1:1986, Conica/ fittings with a 6 % fLuer) taper for syringes, needles and certain other medical equipment -- Part 1: General requirements. ISO 594-2:1991, Conica/ fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings. ISO 3696:1987, Water for ana/ytica/ /aboratory use -- Specification and test methods. 4 Nomenclature The nomenclature for components of hypodermic syringes for single use is shown in figure 1. 1 IS 10258:2002 ISO 7886-1 :1993 1 \ -- -- -- --5 -- -- /1° 2< 3 \ -- -- -10 :;x-~1 ,--/ ----- . /" ` 12 4/ 5 6 / 7 /13 /`4 1.Zero graduation line 2. Graduation lines 3. Nominal capacity graduation line 4. Total graduated capacity line 5. 6. 7. 8. 9. Fiducial line Finger grips Nozzle caD Nozzle Iurkrz Nozzle 10. 11. 12. 13. 14. Barrel Pieton Seal Plunger Push-button NOTE -- The drawing ia intended to be illustrative of component construction and may or may not incorporate more than one seal. of a sYrin9e. The PiSt0rVPlun9er aa.=mbly maY or maY not be of im%lrel Figure 1 -- Schematic representation of hypodermic syringefor single use 2 IS 10258:2002 ISO 7886-1 : 1993 5 Cleanliness mium content 0,1 mg/1. 8 of the control fluid, be lower than viWhen inspected by normal or corrected-to-normal sion without magnification under an illuminance Of 300 lx to 700 lx: the surface of the hypodermic syringe which comes in contact with injection fluids during normal use shall be free from particles and extraneous matter. Lubricant interior surfaces of the syringe, including the are lubricated, the lubricant shall not be visible, normal or corrected-to-normal vision, as dropparticles. If the piston, under lets or 6 Limits for acidity or alkalinity meter and value of an A shall be fluid. An `acceptable lubricant, applied undiluted, for threepiece syringes is polydimethylsiloxane complying with When determined with a laboratory pH using a general purpose electrode, the pH extract prepared in accordance with annex within one unit of pH of that of the control a national or the European pharmacopoeia. The quantity of lubricant used should not exceed 0,25 mg per square centimetre of the internal surface area of the syringe barrel. An acceptable lubricant for two-piece syringes is fatty acid amides of erucic and/or oleic acids. The quantity of the of lubricant should not exceed 0,6 YO (rdm) mass of the barrel, but attention is drawn to the fact that some national regulations may specify a lower maximum conc,eptration. 7 Limits for extractablemetals When tested by a recognized microanalytical method, for example by an atomic absorption method, an extract prepared in accordance with annex A shall, when corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/1 of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cad- 9 Toleranceon graduated capacity capacity shall be as The tolerances on the graduated given in table 1. Table 1 -- Cap Icitv tolerance, dead aoa( I. scaledimensions and test forces Tolerance on any g rnduatadcapacfty Nominal capacity of syringe, V I ] m r Lace than half nominal capacity Equal to or greatar than half nominal capacity q pace I 0,075 Minimum ovarall length of ecaleto nominal capacity mark Scala interval Increment betwean graduation Iinaa to ba numberad II Forcee for Iaakaga taa~ing (see annex D) Side forco (*5%) Axial praeersre (gauge) (*5%) mmlmllml\NlkPa 57 I 0,05 I 0,1 I 0,25 ] 300 + +- 4 % of expelled volume + 4 % of expelled volume 0,10 44 1,0 "2,0 5 3,0 300 & 30< V<50 50